Simultaneous Carotid Artery Stenting Using Micronet-covered CGuard Stent and Cardiac Surgery for Patients at High Stroke Risk
Led by John Paul II Hospital, Krakow · Updated on 2021-07-22
50
Participants Needed
1
Research Sites
260 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the outcomes of patients with symptomatic or critical carotid artery narrowing who also have severe coronary artery disease andor serious heart valve disease. These patients are at risk of stroke and require urgent cardiac surgery. The study focuses on a combined approach where carotid artery treatment and cardiac surgery are done simultaneously under one anesthesia to reduce complications. This open-label, single-arm clinical registry gathers data on the safety and success of this combined treatment strategy.
The treatment involves placing a MicroNet-covered stent CGuard in the carotid artery to prevent stroke, followed immediately by cardiac surgery such as coronary artery bypass grafting or valve repairreplacement. The procedures are performed in a hybrid operating room with backup extracorporeal circulation ready if needed. The approach is guided by a multidisciplinary team including heart and neurovascular specialists, aiming for the safest management in high-risk patients.
Participants will undergo the combined procedure under single anesthesia and receive routine follow-up visits and tests over time. Researchers will assess major cardiovascular and neurological events within 30 days and up to five years after the procedure. They will also monitor procedural success, complication rates, stroke recurrence, heart symptoms, and artery function using clinical evaluations and ultrasound imaging. The study tracks long-term outcomes to understand the feasibility and safety of this simultaneous treatment approach.
CONDITIONS
Brief Title
Simultaneous Cardiac Surgery and Micronet-covered Stent Carotid Revascularization in High Perioperative Stroke Risk Patients
Research Team
P
Piotr Musialek, MD, DPhil
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Patients recommended for combined carotid artery stenting and cardiac surgery by Heart Team and NeuroVascular Team
Signed informed consent form
Agreed to routine follow-up visits and tests during long-term follow-up
Presence of new or recurrent atherosclerotic lesions
Symptomatic carotid artery stenosis ≥50% within past 6 months or asymptomatic stenosis 70-80% by angiography
Confirmed multivessel coronary artery disease or left main stenosis with unstable angina or non-ST-elevation myocardial infarction
Severe symptomatic valvular heart disease detected by echocardiography
You will not qualify if you...
Expected survival less than 1 year (e.g., due to cancer)
Severe kidney failure with GFR less than 20 ml/min/1.73 m2
Pregnant women
Blood clotting disorders
Allergy to contrast agents not responding to treatment
Complete carotid artery blockage
Existing carotid stent extending into the aortic arch
Anatomical issues preventing stent placement
Significant narrowing of the common carotid artery before the target lesion
Mobile plaques in the aortic arch
Coronary artery anatomy unsuitable for bypass grafting
Lack of suitable vessels for grafting
Presence of porcelain aorta (calcified aorta)
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Simultaneous Cardiac Surgery and Carotid Artery Stenting
Duration - Single procedure day
Participants undergo a combined procedure of carotid artery stenting using the MicroNet-covered CGuard stent and cardiac surgery (such as coronary artery bypass grafting or valve replacement/repair) under single anesthesia with extracorporeal circulation backup.
1 procedure visit (in-person)
Post-operative Follow-up
Duration - Up to 5 years
Participants are monitored for recovery and any complications following the simultaneous cardiac and carotid artery procedures.
Regular follow-up visits at 30 days, 6 months, 12 months, and annually up to 5 years
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Endovascular carotid revascularization under open-chest extracorporeal circulation combined with cardiac surgery in unstable patients at increased risk of carotid-related stroke: SIMultaneous urgent cardiac surgery and MicroNet-covered stent carotid revascularization in extreme-risk patients-SIMGUARD Study.
Karolina Dzierwa, Anna Kedziora, Lukasz Tekieli...